Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT DURING PREPARATION FOR A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REMOVED FROM THE PRODUCT PACKAGING AND PREPARED FOR USE. THE SCRUB TECHNICIAN REPORTEDLY FLUSHED THE CATHETER WHILE IT REMAINED WITHIN THE PROTECTIVE TUBING, AND RESISTANCE WAS NOTED DURING FLUSHING. AFTER REMOVAL FROM THE PROTECTIVE TUBING, A DISTAL SHAFT KINK WAS REPORTEDLY OBSERVED. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT USED FOR PATIENT TREATMENT, AND AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT REPORTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME. THE DEVICE WAS RETURNED TO Q'APEL MEDICAL ON 4/20/2026 AND UNDERWENT PRODUCT EVALUATION ON 4/23/2026. THE RETURNED PRODUCT EVALUATION IDENTIFIED FINDINGS THAT ARE INCONSISTENT WITH THE REPORTED EVENT DESCRIPTION. VISUAL INSPECTION IDENTIFIED A SEVERE PROXIMAL SHAFT KINK/FRACTURE APPROXIMATELY 10-11 CM FROM THE HUB/STRAIN RELIEF. WHEN FLUSHING THE CENTRAL LUMEN, LEAKAGE FROM THE FRACTURED REGION CONFIRMED A LUMEN BREACH. ADDITIONALLY, BLOOD WAS OBSERVED EXITING THE DISTAL TIP OF THE CENTRAL LUMEN DURING FLUSHING, SUGGESTING THE DEVICE MAY HAVE BEEN EXPOSED TO BLOOD OR INTRODUCED DURING PROCEDURAL USE. THE CONDITION OF THE RETURNED DEVICE IS NOT CONSISTENT WITH THE INITIALLY REPORTED DISTAL SHAFT KINK IDENTIFIED DURING PREPARATION FOR USE AND NOT USED FOR TREATMENT, AND THE RELATIONSHIP BETWEEN THE RETURNED DAMAGE AND THE ORIGINALLY REPORTED EVENT COULD NOT BE DEFINITIVELY DETERMINED. THE EXACT SEQUENCE OF EVENTS, TIMING OF DAMAGE OCCURRENCE, AND DEVICE USE STATUS COULD NOT BE DEFINITIVELY DETERMINED. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. Q'APEL CONTINUES TO MAKE GOOD FAITH EFFORTS TO RECONCILE THE EVENT INCONSISTENCIES. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.